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Anticoagulant
Tinzaparin for Kidney Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No signs or symptoms of bleeding within the past 4 weeks
No uncontrolled severe intercurrent illness, including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will give tinzaparin to patients with metastatic kidney cancer to see if it can help.
Who is the study for?
This trial is for adults with metastatic kidney cancer that can't be surgically removed. They should have a certain type of cancer cell (clear cell histology), no brain metastases, and their major organs must function well. They need to survive more than 2 months, not be pregnant or nursing, and use effective contraception.Check my eligibility
What is being tested?
The trial is testing Tinzaparin's effectiveness in stopping the growth of kidney cancer by blocking blood flow to the tumor. It's a phase I/II study which means they're looking at how safe it is and how well it works.See study design
What are the potential side effects?
Potential side effects may include bleeding risks due to Tinzaparin’s blood-thinning properties, allergic reactions if sensitive to heparin or related substances, and possibly injection site discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had any bleeding in the last month.
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I don't have any severe illnesses or conditions that are not under control.
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I can care for myself and am up and about more than 50% of my waking hours.
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My kidney cancer is confirmed to be of a specific type under the microscope.
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I don't have blood clots that need blood thinners during the study.
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My cancer has spread beyond the regional lymph nodes and cannot be surgically removed.
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I can receive shots under my skin at home.
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I haven't had significant bleeding or conditions that increase my risk of bleeding recently.
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I do not have diabetic eye problems or a history of bleeding in the eye.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood markers or coagulation as measured by plasma prothrombin F1.2, thrombin-antithrombin complexes, and D-dimers at 2 weeks, 2 months and 6 months
Secondary outcome measures
Blood markers of angiogenesis as measured by serum vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) at 2 weeks, 2 months, and 6 months
Progression free survival as measured by clinical evaluation at 4 months
Venous thromboembolism as measured by clinical evaluation at 6 months
Find a Location
Who is running the clinical trial?
University of VermontLead Sponsor
266 Previous Clinical Trials
3,743,656 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,118 Total Patients Enrolled
Deborah L. Ornstein, MDStudy ChairYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any sex hormones except for postmenopausal hormone replacement.I am currently taking corticosteroids for an urgent condition.It has been over 4 weeks since my last cancer treatment.I have recovered from my previous cancer treatments.I am not receiving any other cancer treatments.I haven't had any bleeding in the last month.I don't have any severe illnesses or conditions that are not under control.I can care for myself and am up and about more than 50% of my waking hours.My kidney cancer is confirmed to be of a specific type under the microscope.I am currently taking medication to prevent blood clots.I am not on any blood thinners or clot-dissolving drugs.More than half of my tumor is clear cell type.I don't have blood clots that need blood thinners during the study.My cancer has spread beyond the regional lymph nodes and cannot be surgically removed.My only cancer site can't be removed with surgery.I do not have cancer that has spread to my brain.I haven't been on blood thinners for more than a month in the last 6 months.I haven't taken any blood thinners, including low molecular weight heparin, in the last month.I haven't had any spinal or epidural procedures in the last 2 days.I am not currently receiving chemotherapy or immunotherapy.I am not currently receiving palliative radiotherapy.I can receive shots under my skin at home.I haven't had cancer in the last 5 years, except for skin cancer or cervical pre-cancer that was successfully treated.I haven't had significant bleeding or conditions that increase my risk of bleeding recently.I do not have diabetic eye problems or a history of bleeding in the eye.I don't have high blood pressure, stomach ulcers, or recent bleeding.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment still open to accepting new participants?
"Per clinicaltrials.gov, this particular medical trial is not currently taking on any new participants. It was initially posted in December of 2005 and revised 8 years later in November of 2013; however, there are 423 alternative trials recruiting right now."
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